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galectin therapeutics inc (GALT) Key Developments

Galectin Therapeutics Announces Details of Design of its Phase 2 Program With GR-MD-02

Galectin Therapeutics announced details of the design of its Phase 2 program with GR-MD-02 in patients with advanced fatty liver disease, or nonalcoholic steatohepatitis (NASH) with cirrhosis. The program includes two clinical studies. The first is a multicenter, randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis (the NASH-CX trial). This trial is expected to commence in the second quarter of 2015 with data readout expected in the fourth quarter of 2017. In addition, the Company will conduct a smaller trial of shorter duration in NASH patients with advanced fibrosis (the NASH-FX trial). The NASH-CX trial was designed with guidance from the U.S. Food and Drug Administration (FDA) received during an End-of-Phase 1 meeting. The NASH-CX trial will include 45 sites (and up to 60 sites, if necessary) in the U.S. and Canada and will enroll a total of 156 patients. It will be comprised of three parallel treatment arms of 52 patients each, with one arm receiving 8 mg/kg of GR-MD-02, the expected therapeutic dose, one arm receiving 2 mg/kg of GR-MD-02 and a third arm receiving placebo. Patients will receive a total of 26 infusions every other week for one year and will be evaluated to determine the change in the hepatic venous pressure gradient (HVPG) as compared with placebo. The FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. HVPG will be correlated with secondary endpoints of fibrosis on liver biopsy as well as with measurement of liver stiffness (FibroScan®) and assessment of liver metabolism (13C-methacetin breath test, Exalenz), which are non-invasive measures of the liver that may be used in future studies. Galectin is finalizing a submission to the FDA by the end of February for a Special Protocol Assessment (SPA) to accept this trial, if positive, as one of the required trials to support approval of the drug candidate. The FDA has previously agreed to review this study protocol for acceptance under an SPA.

Galectin Therapeutics, Inc. Presents at RedChip Global Online CEO Conference, Jan-28-2015 11:30 AM

Galectin Therapeutics, Inc. Presents at RedChip Global Online CEO Conference, Jan-28-2015 11:30 AM.

Galectin Therapeutics, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

Galectin Therapeutics, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported net loss applicable to common stock of $3,853,000 or $0.17 per basic and diluted share against $3,723,000 or $0.21 per basic and diluted share a year ago. Total operating loss was $3,477,000 against $3,545,000 a year ago. For the nine months, the company reported net loss applicable to common stock of $12,992,000 or $0.60 per basic and diluted share against $18,836,000 or $1.15 per basic and diluted share a year ago. Total operating loss was $11,696,000 against $9,300,000 a year ago.

Galectin Therapeutics Inc Presents Data from Phase 1 Clinical Trial of GR-MD-02 in Nash (Fatty Liver Disease) Patients with Advanced Fibrosis

Galectin Therapeutics Inc. presented data from the company's Phase 1 clinical trial of GR-MD-02 in NASH (fatty liver disease) patients with advanced fibrosis at The Liver Meeting in Boston, Massachusetts. Stephen A. Harrison, MD, Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston and a clinical trial investigator in Galectin Therapeutics' Phase 1 clinical trial, shared the data during an oral presentation at the 65(th) Annual Meeting of the American Association for the Study of Liver Diseases. The Phase 1 first-in-man study evaluated the safety, tolerability, and drug pharmacokinetics for single and multiple doses of galectin-inhibiting drug GR-MD-02 when administered to patients with NASH (fatty liver disease) with advanced fibrosis. Additionally, exploratory serum biomarkers were evaluated as potential tools that may be used to aid in future studies. Dr. Harrison reviewed previously-reported results from the ongoing Phase 1 clinical trial including completed cohorts 1 and 2 and also presented, for the first time, interim data from completed patients from cohort 3. In the three-cohort design, eight patients (6 active drug and 2 placebo) completed cohort 1 at the 2 mg/kg dosage; nine patients (7 active drug and 2 placebo) completed cohort 2 at the 4 mg/kg dosage; and nine patients (6 active drug and 3 placebo) have so far completed cohort 3 at the 8 mg/kg dosage. Therefore, there was a similar number of patients from each of the cohorts for comparison purposes. Overall, data from the multi-center, partially blinded Phase 1 trial showed that administration of 2, 4 and 8 mg/kg lean body weight of GR-MD-02 intravenously for four doses over 6 weeks was safe and well tolerated. Thus, the primary endpoint of the study has been met. There were no serious adverse events reported in any of the three cohorts and mild (grade 1) adverse events possibly related to study drug were found in 3 placebo patients and only 2 patients receiving active drug. In cohorts 1 and 2, pharmacokinetic data demonstrated a proportional increase in total drug exposure with doubling of the dose of GR-MD-02 with no accumulation after four doses. In newly released data from cohort 3, Dr. Harrison reported that pharmacokinetic analysis of GR-MD-02 plasma levels for the 8 mg/kg dose provides drug coverage in the upper portion of the targeted therapeutic range derived from NASH animal model studies. An evaluation of exploratory serum biomarkers in all three cohorts revealed that the vast majority of biomarkers do not seem to be useful tools to aid in the design of short-term therapeutic trials. These exploratory biomarkers showed marked variability over time in placebo patients as well as active drug patients. In contrast to other biomarkers, FibroTest(R), a composite score that has been correlated with the extent of liver fibrosis, was significantly reduced by GR-MD-02 treatment in cohort 3. The treatment effect on FibroTest score was due to a statistically significant reduction of alpha-2 macroglobulin, one of the components of the score. This reduction in FibroTest score and alpha-2 macroglobulin was only seen in the high dose cohort 3 and not in cohort 1 and 2. Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis.

Galectin Therapeutics, Inc. Presents at LD Micro Conference, Dec-03-2014 11:30 AM

Galectin Therapeutics, Inc. Presents at LD Micro Conference, Dec-03-2014 11:30 AM. Venue: Luxe Sunset Boulevard Hotel, 11461 Sunset Boulevard, Los Angeles, California, United States. Speakers: James C. Czirr, Executive Chairman.


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